CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
GE Centricity PACS Workstation recalled by GE Healthcare It
GE Healthcare It is recalling GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and, distributed nationwide in the US. The recall was initiated on 15 Nov 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2579-2016
- FDA event ID
- 64785
- Recalling firm
- GE Healthcare It, Barrington, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Nov 2012
- FDA classified
- 17 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Nov 2012 | Recall initiated by company | |
| 17 Aug 2016 | Classified by FDA | +1371 days |
| 24 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
Product as listed by the FDA
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
Where it was distributed
Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
Questions about this recall
Why was it recalled?
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
Which lots are affected?
Centricity PACS versions 3.1.1.x through 3.2.1.x
Where was it sold?
Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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